Novel Cancer Diagnostic to Utilize Urine Instead of Blood Samples

Trovagene Striving for Year-end Cancer Detection Test, and Its Newly Acquired Lab Expected to Aid Development of Tests in Other Areas

SAN DIEGO -- Scientists at Trovagene, Inc. (Pink Sheets: TROV.PK), a developer of trans-renal molecular diagnostics, are working to develop novel tests to detect tumor-derived DNA in cancer patients through a patient's urine, rather than blood samples.

"By the end of the year, we hope to introduce a novel k-RAS gene test that detects mutations in pancreatic and colon cancers," said Antonius Schuh, Trovagene's Chief Executive Officer.

There are an estimated 30,000 to 40,000 new cases of pancreatic cancer each year, while colon cancer afflicts 100,000 new patients a year in the U.S. alone.

The acquisition of MultiGen Diagnostics will enable Trovagene to offer tests incorporating its trans-renal molecular diagnostics technologies through its own clinical laboratory operations and also expands the company's test menu into sequencing based infectious disease tests.

"MultiGen's assay technology, based on multiplexed sequencing, is very synergistic with our trans-renal platform," said Schuh. "This technology may be helpful for our development efforts for urine-based infectious disease tests."

The 48-year old CEO said Trovagene's technology can be useful in a broad range of clinical situations and the company will seek development partners for a range of diagnostic opportunities.

But for now, he said Trovagene will market MultiGen's panel of up to eight tests for sexually transmitted diseases (STDs), which represent a far more widespread clinical problem than is generally appreciated.

"The key reason to purchasing MultiGen was to allow us to go forward to offer diagnostic tests," said Schuh, adding that Trovagene will serve physicians in California and elsewhere.

MultiGen is a CLIA-certified laboratory authorized to do business in California, and is accredited by the College of American Pathologists (CAP), which is recognized in many states in the nation.

"The discovery that DNA and other nucleic acids, which circulate in the blood stream, pass through the kidney and can be detected in urine (trans-renal nucleic acids) was highly significant," said Schuh. "This is our intellectual property foundation."

While Trovagene took action to expand at a time of retrenchment in the California biotech landscape, Schuh said he saw the purchase of MultiGen as an opportunity.

"In every crisis, there is a challenge that the economic conditions put in front of enterpreneuers," said Schuh, who holds a degree in pharmaceutics and earned his Ph.D. in pharmaceutical chemistry. "I believe good technology will be successful in good times and bad times."

It was this kind of vision that led Schuh to join Sequenom (Nasdaq: SQNM) in 1996 as Managing Director of Sequenom Germany. He was instrumental in raising $50 million in private funding and set the strategy on which the company went public. He was named Sequenom's CEO in 2000.

His fundraising success continued even in bad times, as in 2009 when the Dow was wallowing around 6,500.

Schuh led the way in raising funds for Sorrento Therapeutics, Inc., from a company of billionaire pharmaceutical entrepreneur and TEVA chairman Phillip Frost and then later merged with with a public company supported by Frost.

His experience with one of his prior companies is serving Schuh well in his quest for the cancer tests.

Schuh was founding CEO of AviaraDx, Inc., a cancer diagnostic company formed on the basis of technology spun out of Arcturus Biosciences. In 2008, leading French diagnostic company bioMerieux acquired the company and has been growing the business successfully under the name bioTheranostics, Inc.

In building his staff of experts at Trovagene, Schuh has tapped one of his most valuable and longtime colleagues as Chief Financial Officer, Stephen Zaniboni, who has compiled an enviable record of raising more than $500 million through venture financing and IPO proceeds.

Zaniboni, a Certified Public Accountant, goes back with Schuh to Sequenom, Sorrento Therapeutics, and AviaraDx, where he served as CFO and played an important role in the company's sale to bioMerieux.

Schuh also announced the appointment of Charlie Rodi, an innovator in the detection of nucleic acids, as TrovaGene Vice President and Chief Technology Officer.

Rodi, while at G.D. Searle, was among the first to use nucleic acid biomarkers in the development of pharmaceuticals. He also was director of the Monsanto Genome Sequencing Center and earlier served as Executive Vice President, Genomics at Sequenom. He has been awarded several NIH grants in the area of infectious diseases.